Korean Registry of Non-Small Cell Lung Cancer Patients with EGFR Mutation

Active, not recruiting

• Conditions: NSCLC

• Registration Number: NCT06247280
• Lead Sponsor: Yuhan Corporation

Brief Summary

Korean Registry of Non-Small Cell Lung Cancer Patients with EGFR mutation to collect and analyze the patient's clinical features, diagnosis, and treatment results.

Detailed Description

The Korean EGFR Registry is a prospective multicenter observational cohort study designed to enroll all stage EGFR-mutated non-small cell lung cancer (NSCLC) patients. However, due to the extended follow-up period required to confirm clinical outcomes, a retrospective cohort has been included. This retrospective cohort comprises patients with recurrent or metastatic NSCLC who began taking EGFR TKI after January 2021. The recruitment phase was planned to span 36 months, commencing in May 2022, with scheduled follow-up activities continuing until December 2026. The target enrollment for this study is set at 2,000 patients, with competitive enrollment to be carried out across 40 university hospitals in Korea.

Study Timeline

• Study Start: 2022-06-24
• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2001

Inclusion Criteria

1. Adults over 20-year-old with Korean nationality
2. A person who voluntarily signed the informed consent form for this study
3. All stage Non small cell lung cancer patients with EGFR mutation or Metastatic or recurred EGFR mutated NSCLC patients started with EGFR TKI treatment from 2021-01-01.

Exclusion Criteria

1. A person who is not confirmed NSCLC histologically or cytologically.
2. A person who doesn't consent to the study.
3. A person who is unable to complete the study judged by the investigator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical characteristics of NSCLC patients with EGFR mutation	12months, 18months, 24months, 36months	Analysis of clinical characteristics and clinical outcomes in NSCLC patients with EGFR mutation
PFS	12months, 18months, 24months, 36months	PFS underwent palliative therapy according to stages in NSCLC patients with EGFR mutation
Clinical outcome of NSCLS patients with EGFR mutation	12months, 18months, 24months, 36months	Analysis of clinical characteristics and clinical outcomes in NSCLC patients with EGFR mutation
DFS	12months, 18months, 24months, 36months	DFS in patients underwent definitive therapy according to stages in NSCLC patients with EGFR mutation

Secondary Outcome Measures

Name	Time	Method
DoR (duration of response)	up to 36months	Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
TTF (time to treatment failure)	up to 36months	Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
Analysis of metastatic sites and treatment patterns (especially brain and bone metastasis)	up to 36months	Exploration of clinical characteristics and metastatic patterns in NSCLC patients with EGFR mutation
OS(Overall survival)	up to 36months	Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
Adverse event profiles	up to 36months	Adverse event profiles after lazertinib administration
DCR (disease control rate)	up to 36months	Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
TTNF (time to next treatment)	up to 36months	Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
ORR(overall response rate)	up to 36months	Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
Diagnosis Test Method	up to 36months	Proportion of diagnostic test methods according various clinical samples

Trial Locations

Locations (39)

Kyungpook National University Chilgok Hospital; 🇰🇷 Chilgok, Daegu, Korea, Republic of

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Gangwon-do, Korea, Republic of

Hallym Univ. Medical Center. Chuncheon; 🇰🇷 Chuncheon, Gangwon, Korea, Republic of

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Bucheon-si, Gyeonggi-do, Korea, Republic of

The Catholic University of Korea Uijeongbu St. Mary's Hospital; 🇰🇷 Uijeongbu, Gyeonggi-do, Korea, Republic of

The Catholic Univ. of Korea Bucheon ST. Mary's Hospital; 🇰🇷 Bucheon, Gyeonggido, Korea, Republic of

Wonkwang University Hospital; 🇰🇷 Iksan, Jeonbuk, Korea, Republic of

Inje University Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

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